Overview
Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
Status:
Completed
Completed
Trial end date:
2016-08-19
2016-08-19
Target enrollment:
0
0
Participant gender:
All
All
Summary
Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in patients with selected solid tumors.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
PharmaMarCriteria
Inclusion Criteria:- Voluntarily signed and dated informed consent
- Normal cardiac conduction and function (centrally read)
- Blood pressure between 90 and 150 mmHg systolic, inclusive, and not higher than 90
mmHg diastolic.
- Specific serum electrolyte levels
Exclusion Criteria:
- Age > 65 years
- Performance status = 2 [Eastern Cooperative Oncology Group (ECOG)]
- Heart rhythm disturbances
- Significant ischemic coronary disease, heart failure, myocardial infarction, or
unstable angina within the last six months.
- Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) >
450 mg/m²